TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)

NCT00440401 | Completed Phase 4 Results DMC

• 1 other identifier: TC-023-IM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Conditions

Haemorrhage; Haemostasis; Cardiovascular Surgery

Keywords

Surgical treatment of haemorrhage

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving Haemostasis at 3 Minutes

  Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.

  3 minutes

Secondary Outcomes (1)

• Proportion of Subjects Achieving Haemostasis at 6 Minutes.

  6 minutes

Study Arms (2)

TachoSil®

ACTIVE COMPARATOR

Drug: fibrinogen (human) + thrombin (human)

Standard Treatment

ACTIVE COMPARATOR

Standard Treatment of haemorrhage in cardiovascular surgery

Drug: Standard haemostatic treatment in cardiovascular surgery

Interventions

fibrinogen (human) + thrombin (human) DRUG

TachoSil®

Standard haemostatic treatment in cardiovascular surgery DRUG

Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At Screening:
• Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
• For female subjects of childbearing potential: Is the pregnancy test at screening negative?
• Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
• Is the subject ≥ 18 years of age?
• Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
• Intra operative (after primary haemostatic treatment):
• Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
• Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
• Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?

You may not qualify if:

• At Screening:
• Does the subject participate in a clinical trial concomitantly with the present trial?
• Is the subject undergoing an emergency operation?
• Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
• Is the subject suffering from known coagulopathy?
• Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
• Is the female subject pregnant or breast feeding?
• Intra operative (after primary haemostatic treatment):
• Has liquid fibrin sealant/glue or TachoSil® been applied?
• Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrinogen; Thrombin; Cardiovascular Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Surgical Procedures, Operative

Results Point of Contact

• Title: Medical Responsible
• Organization: Medical Scientific Strategy

clinicaltrials@nycomed.com

+45 4677 1111

Study Officials

• Nycomed Clinical Trial Operations

  Headquaters

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 8, 2012
• Results First Posted: June 4, 2010

Record last verified: 2010-07

Locations

DK (1)